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The Clinical Impact of the Novel Alzheimer's Blood-based Biomarkers

NCT06246019 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-02-28

No results posted yet for this study

Summary

The goal of this observational study is to determine whether the early adoption of blood-based biomarkers for Alzheimer's disease is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in patients presenting with cognitive complaints in a Cognitive Disorders Unit from a public hospital.

The main questions it aims to answer are:

1. Does the early adoption of blood-based biomarkers in clinical practice enable an earlier etiologic diagnosis with high confidence compared to the late adoption of blood-based biomarkers in the patients with cognitive complaints that are admitted in a Cognitive Disorders Unit?
2. Is the early adoption of blood-based biomarkers in clinical practice associated with changes in clinical management compared to their late adoption?
3. Is the early adoption of blood-based biomarkers in clinical practice associated with a lower emotional impact in the patients and their study partners/caregivers compared to their late adoption?
4. Are blood-based biomarkers better tolerated than other tests and preferred by patients for the diagnostic work-up?
5. Does blood-based biomarkers have an impact in the cost of the diagnostic workup and clinical management of the patients that are admitted in a Cognitive Disorders Unit?

Participants will be asked to:

* Perform a blood extraction for blood-based biomarkers analysis at the beginning of the study.
* Complete specific scales in each visit.

Researchers will compare the group in which blood biomarkers are delivered at 3 months with the group in which they are delivered at 9 months to assess whether early adoption of blood-based biomarkers is associated with an impact on etiological diagnosis, patient's management, emotional impact, patient's preferences and cost-effectiveness in a specialized memory unit.

Conditions

Interventions

DIAGNOSTIC_TEST

Early adoption of blood-based biomarkers for Alzheimer's disease

A blood test will be performed to obtain plasma measures of Amyloid-β (Aβ) 42/40, phosphorylated tau (p-tau) 181, p-tau217, p-tau231 and Glial fibrillary acidic protein (GFAP) and Neurofilament light chain (NfL) and results will be disclosure to the early and late arms at different time points.

Sponsors & Collaborators

  • Hospital del Mar Research Institute (IMIM)

    lead OTHER

Principal Investigators

  • Marc Suárez-Calvet, MD PhD · Hospital del Mar Research Insititute (IMIM)

  • Albert Puig-Pijoan, MD · Hospital del Mar Research Insititute (IMIM)

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06246019 on ClinicalTrials.gov